The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures. 

WORKING AT GENEZEN

Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.

PURPOSE

Collaborate with all sections of the organization—including the client quality teams, external suppliers, external regulatory agencies, and technical operations. Help build scalable Quality systems as the organization continues to grow.

ESSENTIAL JOB FUNCTIONS / DUTIES

  • Act as a leader in the Quality organization, helping define and drive the Quality vision, mindset, and culture of the entire company in close collaboration with the Vice President of QA and Regulatory
  • Develop overall program, implementation, and continuous improvement of the Quality Systems, which encompass but not limited to: QMS (Deviation, Change Control, CAPA), Documentation, Training, Supplier Management, Internal/Customer Audits and Customer Complaints.
  • Ensure that Quality Systems are designed and operating in a way to provide appropriate support in all GxP areas of the company and are in compliance with current ISO and GMP standards (cGMP) both US FDA and EU applicable to gene therapy as appropriate for early phase clinical trials
  • Develop, implement, and maintain corporate policy and procedures for the Quality Management System in accordance with ICH Q10 model
  • Take lead role in evaluating continuous improvement options for the Quality Systems post initial implementation
  • Develop user requirements and contribute to the configuration, validation, implementation, and lifecycle management of the electronic Quality Management System (eQMS - Veeva)
  • Develop, implement, and oversee a Quality Supplier Management Program that serves all GxP areas including introduction and qualification of suppliers and materials, supplier material changes, supplier complaints
  • Establish department / individual goals and key performance indicators in alignment with company and operational goals
  • Maintain and report applicable department and delivery metrics
  • Manage the site monthly Quality Management Review meeting.
  • Facilitate creation of the presentation materials to include the Key Performance indicators, the meeting agenda, and attendance, and to orchestrate the material presentation
  • Manage internal quality improvement initiatives: evaluate internal processes, suggest/design/implement improvements, create/revise relevant SOPs/Policies
  • Act as subject matter expert and provide training on all Quality Management Systems, including but not limited to change control, quality events, investigation, and implementation of effective CAPAs
  • Own and oversee the compilation of the Site Master File (SMF)
  • Support other members of the Quality Team and organization during its growth period in aspects not related to the core responsibilities of the Quality Systems area
  • Coach, train, and develop the Quality Systems team
  • Develop budget for department and ensure adherence to the budget
  • Drive continuous improvement and operational excellence culture through self-detecting and self-correcting processes and systems and instilling strong ownership and accountability
  • Ensure safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies within the QA department

SPECIAL JOB REQUIREMENTS

  • Adaptability required as work schedule may change based on business needs
  • Criminal background check and drug screen required
  • Other duties as assigned

KNOWLEDGE, SKILLS & EXPERIENCE

EDUCATION / CERTIFICATIONS / LICENSES

Essential/Desired

BS degree in science or related field

Essential

In depth Knowledge in industries regulated in-part by, 21 CFR Part 11, 21 CFR 210, 21 CFR 211, 21 CFR 600, 21 CFR 610, Eudralex Volume 4, ICH Quality Guidelines, and Guidance to Industry dockets, as applicable for early phase clinical trials

Essential

Certified Auditor

Desired

ON-THE-JOB EXPERIENCE

 

10+ years of experience Quality Professional in Pharmaceutical and/ or Biological Manufacturing

Essential

7+ years of experience Quality Systems

Essential

3+ years of experience Quality Management

Desired

Experience conducting Supplier Audits, including for API

Essential

Experience with Phase I/II IND clinical trials

Desired

SKILLS / ABILITIES

 

Manage multiple projects, set priorities, and work in fast-paced environment

Essential

Communicate confidently and effectively with management, peers, and key stakeholders

Essential

Demonstrate effectiveness in task completion, decision-making, empowerment of others, deviation/nonconformance management, training, and problem solving

Essential

Demonstrated ability to develop quality systems and a quality management plan

Essential

PHYSICAL DEMANDS
While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

  • Occasionally exposed to loud noise levels
  • Position can be combination of remote and on-site
  • Regularly sit for long periods of time

Movement

  • Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
  • Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

  • Frequently lift and/or move up to 10 pounds
  • Occasionally lift and/or move up to 25 pounds

Vision

  • Frequently utilize close vision and the ability to adjust focus

Communication

  • Frequently required to communicate by talking, hearing, using telephone and e-mail

GENEZEN'S VALUE-BASED COMPETENCIES

Growth Mindset
Believe that skill is developed through dedication and hard work.
Intelligence & talent are just the starting point.
Mistakes are valuable lessons, not shameful indictments.

Flexibility
Adapt rapidly to a quickly changing, CDMO environment.
Respond by constructively creating & impacting opportunity through active participation.

Team Focus
Work together; succeed together; fail together.

Integrity
Do the right thing, on time, every time.
Speak up when needed.
Exercise respect.

Inclusion
Embrace the unique viewpoint of each individual.
Join the ongoing journey to a more inclusive workplace and community where we all help each other get better.

GENEZEN'S BENEFITS

  • Paid vacation days, amount based on tenure, and paid sick time
  • 8 observed holidays + 1 floating holiday
  • 401(k) plan with company match up to 6% of salary, vested immediately
  • Choice of six healthcare plans
  • FSA and HSA programs
  • Dental & vision care
  • Employer-paid basic term life/personal accident insurance
  • Voluntary disability, universal life/personal accident insurance

ADDITIONAL DETAILS

  • Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
  • This position is located in Fishers, Indiana.
  • This position requires a criminal background check.
  • Genezen is an Equal Opportunity Employer.
  • Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.

Genezen is located in Fishers, Indiana, a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world’s largest children’s museum--to name just a few reasons why this area is a great place to live.

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